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European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127764
Recruitment Status : Completed
First Posted : August 8, 2005
Last Update Posted : August 30, 2007
Information provided by:
University Medical Center Groningen

Brief Summary:
By this study, the investigators want to test if the value of adjuvant pulse glucocorticoid therapy for pemphigus can be determined by comparing an experimental arm (dexamethasone pulse therapy, prednisolone, and azathioprine) with a control arm (placebo pulse therapy, prednisolone, and azathioprine). The investigators will determine the rate of complete remission with dexamethasone pulse therapy; the time needed for complete remission; and the duration of remission, and compare these data with those of the placebo arm.

Condition or disease Intervention/treatment Phase
Pemphigus Drug: dexamethasone (50mg 1dd6, 3 consecutive days/month) Phase 2 Phase 3

Detailed Description:
Pemphigus is a severe chronic dermatological disease which appears to be incurable. Oral glucocorticoid now forms the cornerstone of treatment. From previous uncontrolled studies it has been suggested, that the use of high dose intravenous glucocorticoid pulse therapy may lead to complete remission without further therapy. Prospective placebo-controlled studies of adjuvant pulse therapy for pemphigus are lacking. This prospective, multi-centre, randomised, double-blind, placebo-controlled trial assesses the efficacy and steroid-sparing effect of oral high-dose glucocorticoid pulse therapy as adjuvant added to the standard combination therapy of prednisone and azathioprine in the treatment of pemphigus vulgaris, in terms of complete remission rate (primary endpoint), initial control, disease control, and adverse events. In the experimental arm glucocorticoid pulse therapy is given, comprising monthly pulses with 300mg oral dexamethasone on three consecutive days. In addition the patients receive daily prednisone and azathioprine treatment, the latter dose adjusted to the thiopurine-methyltransferase level. In the control arm the glucocorticoid pulse therapy is replaced double blindly by monthly oral placebo capsules on three consecutive days. in addition the patients receive the same daily combination schedule with prednisone and azathioprine as in the experimental arm. This study design requires 30 patients in each arm, with one year follow-up. Only new patients with pemphigus vulgaris and/or pemphigus oris are included.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: European Randomised Placebo-Controlled Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus (Pempuls Trial)
Study Start Date : January 2001
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus Steroids

Primary Outcome Measures :
  1. The rate of complete remission with pulse therapy
  2. Number of weeks in complete remission after 12 months

Secondary Outcome Measures :
  1. Time from start of pulse therapy until initial control
  2. Number of weeks in remission until 12 months
  3. Cumulative prednisolone use until 12 months
  4. Number of adverse events reported

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • New patients with diagnosis of pemphigus vulgaris

Exclusion Criteria:

  • Diagnosis of pemphigus different from vulgaris type
  • Current use of adjuvant treatment other than azathioprine. A wash out period of at least 2 weeks is required before inclusion is acceptable.
  • Presence of contra-indications for the use of high dose steroids
  • No availability for follow-up.
  • Concomitant diseases treated with oral steroids.
  • Glucocorticoids administered for pemphigus vulgaris longer than two months.
  • Presence of contra-indications for the use of azathioprine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127764

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Department of Dermatology, University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
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Principal Investigator: Marcel F Jonkman, MD, PhD Department of Dermatology, University Medical Center Groningen
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00127764    
Other Study ID Numbers: 754309
First Posted: August 8, 2005    Key Record Dates
Last Update Posted: August 30, 2007
Last Verified: August 2004
Keywords provided by University Medical Center Groningen:
Additional relevant MeSH terms:
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Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents